Low-cost Enabling Technology for Image-guided Photodynamic Therapy (PDT) of Oral Cancer Cancer.

NCT03638622 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: 2015P0018555UH3CA189901-04
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Oral cancer in India affects mostly those from the lower socioeconomic groups, due to a higher exposure to risk factors such as the use of tobacco, zarda, khaini, chewing gutka, mawa, and kharra, which are all dry mixtures of flavorings, areca nut flakes and powdered tobacco. Earlier detection of oral cancer offers the best chance for long-term survival and has the potential to improve treatment outcomes and make healthcare affordable. Current treatment options, primarily surgery and/or radiation, can be curative if cancer or dysplasia is caught at a sufficiently early stage. Though even in these cases treatment may be disfiguring with significant impact upon quality of life, and many patients do not seek medical attention until the disease has progressed to a point where radical operation is required (Stage III/IV), often entailing block dissection and removal of the entire lymphatic drainage of the neck. Despite the radical operation, the disease still recurs, leading to an overall survival rate of less than 70% of these cases. The present study evaluates photodynamic therapy (PDT) as an alternative intervention for early-stage malignant lesions of the oral cavity using a low-cost and battery-powered platform that is specifically adapted for low and middle-income countries (LMIC) implementation.

Conditions

Oral Cancer

Keywords

Oral cancer, Photodynamic Therapy, Photosensitizer, ALA

Outcome Measures

Primary Outcomes (1)

• Number of Participants With no Residual Tumor Following Photodynamic Therapy (PDT)

  Histologically confirmed the absence of residual disease at follow-up lesion site biopsy (7 days) and from additional clinical examinations during follow-up visits. The follow-up visits happened approximately once every 3 months after treatment until Institutional Review Board (IRB) approval (October 12, 2020).

  Up to 2 years

Study Arms (1)

Aminolevulinic acid (ALA) and Photodynamic Therapy (PDT)

EXPERIMENTAL

Aminolevulinic Acid (ALA) administration, Photodynamic Therapy (PDT) treatment using LED (Light-emitting diode) light source and follow-up.

Combination Product: Photodynamic Therapy

Interventions

Photodynamic Therapy COMBINATION_PRODUCT

Patients receive aminolevulinic acid (ALA) orally with orange juice in 3 fractions at 0,1,2 hours before undergoing photodynamic therapy using LED based Device on day one.

Also known as: Aminolevulinic acid (ALA), Photodynamic Therapy (PDT), Light Emitting Diode (LED) based Device

Aminolevulinic acid (ALA) and Photodynamic Therapy (PDT)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 21 years, males or females
• Subject has read and signed a written informed consent form
• Subject is willing to have ALA administered and wait for 2-3 hours
• Subject is willing to receive red light irradiation in the mouth via the fiber probe/applicator and is willing to have the fiber probe/applicator in the mouth for a maximum time of 1 hour
• Subject is willing to allow investigators to take measurements using smart phone imaging before, during and after light treatment
• After the procedure, the subject is willing to avoid spicy, hot, or oily foods for at least 6 hours
• Subject willing to wear full sleeve shirt and full-length garments for couple of hours

You may not qualify if:

• Pregnancy or nursing (ALA is a drug that belongs to FDA pregnancy category C).
• History of photosensitivity diseases (e.g., lupus erythematosus, porphyrias).
• Therapy with any photosensitizing medication, e.g., thiazides (for the treatment of high blood pressure), fluoroquinolones, griseofulvin, or sulfonamides (for the treatment of infections), sulfonylureas (for the treatment of diabetes), phenothiazines (for the treatment of emotional problems), and other medications reported to cause photosensitivity within the last 6 months.
• Subject is unable or unwilling to comply with the study requirements.
• Subject has any conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
• Allergy to porphyrins or ALA.
• Subject has received laser treatment within 6 months in the area of the treatment.
• Subject is participating in other potentially confounding research, e.g., currently enrolled in a clinical study of any other unapproved investigational drug or device.
• Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study.
• Subject has inadequate organ function.
• Subject has co-morbid systemic illnesses or severe concurrent disease.
• Subject is being treated for vascular disease.
• Subject is an employee of the participating sites directly supervised by the investigator.
• Subject with invasive deep carcinoma evaluated by biopsy.
• Subject is currently being treated for other cancers with medical or radiation therapy.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Jawaharlal Nehru Medical College: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

J.N. Medical College, Aligarh Muslim University

Aligarh, Uttar Pradesh, 202002, India

Location

Related Publications (1)

• Siddiqui SA, Siddiqui S, Hussain MAB, Khan S, Liu H, Akhtar K, Hasan SA, Ahmed I, Mallidi S, Khan AP, Cuckov F, Hopper C, Bown S, Celli JP, Hasan T. Clinical evaluation of a mobile, low-cost system for fluorescence guided photodynamic therapy of early oral cancer in India. Photodiagnosis Photodyn Ther. 2022 Jun;38:102843. doi: 10.1016/j.pdpdt.2022.102843. Epub 2022 Mar 31.

  PMID: 35367616 DERIVED

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Photochemotherapy; Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Tayyaba Hasan
• Organization: Massachusetts General Hospital, Boston

thasan@mgh.harvard.edu

617-726-6996

Study Officials

• Tayyaba Hasan, PhD

  Massachusetts General Hospital, Boston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Model Details: Trial with single arm

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 20, 2018
• Study Start: March 10, 2017
• Primary Completion: October 12, 2020
• Study Completion: October 12, 2020
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Locations

IN (1)